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The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 801 - 807
1 Jul 2023
Dietrich G Terrier A Favre M Elmers J Stockton L Soppelsa D Cherix S Vauclair F

Aims. Tobacco, in addition to being one of the greatest public health threats facing our world, is believed to have deleterious effects on bone metabolism and especially on bone healing. It has been described in the literature that patients who smoke are approximately twice as likely to develop a nonunion following a non-specific bone fracture. For clavicle fractures, this risk is unclear, as is the impact that such a complication might have on the initial management of these fractures. Methods. A systematic review and meta-analysis were performed for conservatively treated displaced midshaft clavicle fractures. Embase, PubMed, and Cochrane Central Register of Controlled Trials (via Cochrane Library) were searched from inception to 12 May 2022, with supplementary searches in Open Grey, ClinicalTrials.gov, ProQuest Dissertations & Theses, and Google Scholar. The searches were performed without limits for publication date or languages. Results. The meta-analysis included eight studies, 2,285 observations, and 304 events (nonunion). The random effects model predicted a pooled risk ratio (RR) of 3.68 (95% confidence interval 1.87 to 7.23), which can be considered significant (p = 0.003). It indicates that smoking more than triples the risk of nonunion when a fracture is treated conservatively. Conclusion. Smoking confers a RR of 3.68 for developing a nonunion in patients with a displaced middle third clavicle fracture treated conservatively. We know that most patients with pseudarthrosis will have pain and a poor functional outcome. Therefore, patients should be informed of the significantly higher risks of nonunion and offered smoking cessation efforts and counselling. Moreover, surgery should be considered for any patient who smokes with this type of fracture. Cite this article: Bone Joint J 2023;105-B(7):801–807


The Bone & Joint Journal
Vol. 97-B, Issue 11 | Pages 1562 - 1565
1 Nov 2015
Ersen A Atalar AC Birisik F Saglam Y Demirhan M

Only a few randomised, controlled studies have compared different non-operative methods of treatment of mid-shaft fractures of the clavicle.

In this prospective, randomised controlled study of 60 participants (mean age 31.6 years; 15 to 75) we compared the broad arm sling with the figure of eight bandage for the treatment of mid-shaft clavicle fractures. Our outcome measures were pain, Constant and American Shoulder and Elbow Surgeons scores and radiological union.

The mean visual analogue scale (VAS) pain score on the first day after treatment was significantly higher (VAS 1 6.8; 4 to 9) in the figure of eight bandage group than the broad arm sling group (VAS 1 5.6; 3 to 8, p = 0.034). A mean shortening of 9 mm (3 to 17) was measured in the figure of eight bandage group, versus 7.5 mm (0 to 24) in the broad arm sling group (p = 0.30).

The application of the figure of eight bandage is more difficult than of the broad arm sling, and patients experience more pain during the first day when treated with this option. We suggest the broad arm sling is preferable because of the reduction of early pain and ease of application.

Cite this article: Bone Joint J 2015;97-B:1562–5.


The Bone & Joint Journal
Vol. 101-B, Issue 8 | Pages 995 - 1001
1 Aug 2019
Nicholson JA Clement N Goudie E Robinson CM

Aims. The primary aim of this study was to establish the cost-effectiveness of the early fixation of displaced midshaft clavicle fractures. Patients and Methods. A cost analysis was conducted within a randomized controlled trial comparing conservative management (n = 92) versus early plate fixation (n = 86) of displaced midshaft clavicular fractures. The incremental cost-effectiveness ratio (ICER) was used to express the cost per quality-adjusted life-year (QALY). The Six-Dimension Short-Form Health Survey (SF-6D) score was used as the preference-based health index to calculate the cost per QALY at 12 months after the injury. Results. The mean 12-month SF-6D was 0.9522 (95% confidence interval (CI) 0.9355 to 0.9689) following conservative management and 0.9607 (95% CI 0.9447 to 0.9767) following fixation, giving an advantage for fixation of 0.0085, which was not statistically significant (p = 0.46). The mean cost per patient was £1322.69 for conservative management and £5405.32 for early fixation. This gave an ICER of £480 309.41 per QALY. For a threshold of £20 000 per QALY, the benefit of fixation would need to be present for 24 years to be cost-effective compared with conservative treatment. Linear regression analysis identified nonunion as the only factor to adversely influence the SF-6D at 12 months (p < 0.001). Conclusion. Routine plate fixation of displaced midshaft clavicular fractures is not cost-effective. Nonunion following conservative management has an increased morbidity with comparable expense to early fixation. This may suggest that a targeted approach of fixation in patients who are at higher risk of nonunion would be more cost-effective than the routine fixation of all displaced fractures. Cite this article: Bone Joint J 2019;101-B:995–1001


The Bone & Joint Journal
Vol. 100-B, Issue 10 | Pages 1385 - 1391
1 Oct 2018
Qvist AH Væsel MT Jensen CM Jensen SL

Aims. Recent studies of nonoperatively treated displaced midshaft clavicular fractures have shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies have shown superior functional results and higher rates of healing following operative treatment. The aim of this study was to compare the outcome in these patients after nonoperative management with those treated with fixation. Patients and Methods. In a multicentre, parallel randomized controlled trial, 146 adult patients with an acute displaced fracture of the midthird of the clavicle were randomized to either nonoperative treatment with a sling (71, 55 men and 16 women with a mean age of 39 years, 18 to 60) or fixation with a pre-contoured plate and locking screws (75, 64 men and 11 women with a mean age of 40 years, 18 to 60). Outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Score, the Constant Score, and radiographical evidence of union. Patients were followed for one year. Results. A total of 60 patients in the nonoperative group and 64 in the operative group completed one-year follow-up. At three months’ follow-up, both the median DASH (1.7 vs 8.3) and median Constant scores (97 vs 90) were significantly better in the operated group (both p = 0.02). After six months and one year, there was no difference in the median DASH or Constant scores. The rate of nonunion was lower in the operative group (2 vs 11 patients, p < 0.02). Nine patients in the nonoperative group underwent surgery for nonunion. The plate was subsequently removed in 16 patients (25%). One patient had a new fracture after removal of the plate and one underwent revision surgery for failure of fixation. Conclusion. Fixation of a displaced midshaft clavicular fracture using a pre-contoured plate and locking screws results in faster functional recovery and a higher rate of union compared with nonoperative management, but the function of the shoulder is equal after six months and at one year. Cite this article: Bone Joint J 2018;100-B:1385–91


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_4 | Pages 5 - 5
1 Mar 2020
Nicholson J Clelland A MacDonald D Clement N Simpson H Robinson C
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To evaluate if clinical recovery following midshaft clavicle fracture is associated with nonunion and determine if this has superior predictive value compared to estimation at time of injury. A prospective study of all patients (≥16 years) who sustained a displaced midshaft clavicle fracture was performed. We assessed patient demographics, injury factors, functional scores and radiographic predictors with a standardized protocol at six-weeks. Conditional-stepwise regression was used to assess which factors independently predicted nonunion at six-months post-injury determined by CT. The nonunion predictor six-week model (NUP6) was compared against a previously validated model based on factors available at time of injury (NUP0-smoking, comminution and fracture displacement). 200 patients completed follow-up at six months. The nonunion rate was 14% (27/200). Of the functional scores, the QuickDASH had the highest accuracy on receiver-operator-characteristic (ROC) curve analysis with a 39.8 threshold, above which was associated with nonunion (Area Under Curve (AUC) 76.8%, p<0.001). On regression modelling QuickDASH ≥40 (p=0.001), no callus on radiograph (p=0.004) and fracture movement on examination (p=0.001) were significant predictors of nonunion. If none were present the predicted nonunion risk was 3%, found in 40% of the cohort (n=80/200). Conversely if two or more were present, found in 23.5% of the cohort, the predicted nonunion risk was 60%. The NUP6 model appeared to have superior accuracy when compared to the NUP0 model on ROC curve analysis (AUC 87.3% vs 64.8% respectively). Delayed assessment at six-weeks following displaced clavicle fracture enables a more accurate prediction of fracture healing


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_7 | Pages 1 - 1
1 May 2021
Ng N Chen PC Yapp LZ Gaston M Robinson C Nicholson J
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The aim of this study was to define the long-term outcome following adolescent clavicle fracture. We retrospectively reviewed all adolescent fractures presenting to our region (13–17years) over a 10-year period. Patient reported outcomes were undertaken at a minimum of 4 years post-injury (QuickDASH and EQ-5D) in completely displaced midshaft fractures (Edinburgh 2B, >2cm displacement, n=50) and angulated midshaft fractures (Edinburgh 2A2, >30 degrees angulation, n=32). 677 clavicle fractures were analysed. The median age was 14.8 (IQR 14.0–15.7) and 89% were male. The majority were midshaft (n=606, 89.5%) with either angulation (39.8%) or simple fully displaced (39.1%). Only 3% of midshaft fractures underwent acute fixation (n=18/606), all of which were fully displaced. The incidence of refracture following non-operative management of midshaft fractures was 3.2% (n=19/588), all united with non-operative management. Fracture type, severity of angulation or displacement was not associated with risk of refracture. There was one case of non-union encountered following non-operative management of all displaced midshaft fractures (0.4%, n=1/245). At a mean of 7.6 years following injury, non-operative management of both displaced and angulated fractures had a median QuickDASH was 0.0 (IQR 0.0–2.3), EQ-5D was 1.0 (IQR 1.0–1.0). 97% of angulated fractures and 94% of displaced fractures were satisfied with their final shoulder function. We conclude that Non-operative management of adolescent midshaft clavicle fractures result in excellent functional outcomes with a low rate of complications at long-term follow up. The relative indications for surgical intervention for clavicle fractures in adults do not appear to be applicable to adolescents


Bone & Joint Open
Vol. 2, Issue 8 | Pages 646 - 654
16 Aug 2021
Martin JR Saunders PE Phillips M Mitchell SM Mckee MD Schemitsch EH Dehghan N

Aims

The aims of this network meta-analysis (NMA) were to examine nonunion rates and functional outcomes following various operative and nonoperative treatments for displaced mid-shaft clavicle fractures.

Methods

Initial search strategy incorporated MEDLINE, PubMed, Embase, and the Cochrane Library for relevant randomized controlled trials (RCTs). Four treatment arms were created: nonoperative (NO); intramedullary nailing (IMN); reconstruction plating (RP); and compression/pre-contoured plating (CP). A Bayesian NMA was conducted to compare all treatment options for outcomes of nonunion, malunion, and function using the Disabilities of the Arm Shoulder and Hand (DASH) and Constant-Murley Shoulder Outcome scores.


Bone & Joint Open
Vol. 2, Issue 7 | Pages 522 - 529
13 Jul 2021
Nicholson JA Clement ND Clelland AD MacDonald DJ Simpson AHRW Robinson CM

Aims

It is unclear whether acute plate fixation facilitates earlier return of normal shoulder function following a displaced mid-shaft clavicular fracture compared with nonoperative management when union occurs. The primary aim of this study was to establish whether acute plate fixation was associated with a greater return of normal shoulder function when compared with nonoperative management in patients who unite their fractures. The secondary aim was to investigate whether there were identifiable predictors associated with return of normal shoulder function in patients who achieve union with nonoperative management.

Methods

Patient data from a randomized controlled trial were used to compare acute plate fixation with nonoperative management of united fractures. Return of shoulder function was based on the age- and sex-matched Disabilities of the Arm, Shoulder and Hand (DASH) scores for the cohort. Independent predictors of an early recovery of normal shoulder function were investigated using a separate prospective series of consecutive nonoperative displaced mid-shaft clavicular fractures recruited over a two-year period (aged ≥ 16 years). Patient demographics and functional recovery were assessed over the six months post-injury using a standardized protocol.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 762 - 768
1 Apr 2021
Ban I Kristensen MT Barfod KW Eschen J Kallemose T Troelsen A

Aims

To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups.

Methods

Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture were recruited, and randomized to either the operative (n = 60) or nonoperative (n = 60) treatment group. This randomized controlled, partially blinded trial followed patients for 12 months following initial treatment. Functionality was assessed by the Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score. Clinical and radiological evaluation, and review of patient files for complications and reoperations, were added as secondary outcomes.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_7 | Pages 1 - 1
1 May 2019
Nicholson J Clement N Goudie E Robinson C
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The primary aim of this study was to undertake a cost-effectiveness analysis (CEA) of acute fixation versus conservative management of displaced midshaft clavicle fractures. The secondary aim was to conduct a sensitivity analysis of patient characteristics that may influence a threshold of £20,000 per quality-adjusted life year gained (QALY). A CEA was conducted from a randomised control trial comparing conservative management (n=92) to acute plate fixation (n=86) of displaced midshaft clavicle fractures. The incremental cost effectiveness ratio (ICER) was used to express the cost per QALY. The short form 6-dimensional (SF-6D) score was the preference based index to calculate the cost per QALY. The 12-month SF-6D advantage of acute fixation over conservative management was 0.0085 (p=0.464) with a mean cost difference of £4,096.22 and resultant ICER of £481,908.24/QALY. For a threshold of £20,000/QALY the benefit of acute fixation would need to be present for 24.1 years. Linear regression analysis identified nonunion as the only independent factor to influence the SF-6D at 12-months (p<0.001). Conservatively managed fractures that resulted in a nonunion (n=16) had a significantly worse SF-6D compared to acute fixation (0.0723, p=0.001) with comparable healthcare cost at 12-months (£170.12 difference). Modelling the ICER of acute fixation against those complicated by a nonunion proved to be cost effective at £2,352.97/QALY at 12-months. Routine plate fixation of displaced midshaft clavicle fractures is not cost-effective. Patients with nonunion after conservative management have increased morbidity with comparable expense to those undergoing acute fixation which suggests targeting these patients is a more cost-effective strategy


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_18 | Pages 4 - 4
1 Nov 2017
Goudie E Clement N Murray I Wilson M Robinson C
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This study aimed to evaluate the effect of clavicular shortening, measured by three-dimensional computerized tomography (3DCT), on functional outcomes and satisfaction in patients with healed, displaced, midshaft clavicle fractures up to one year following injury. The data used in this study were collected as part of a multicenter, prospective randomized control trial comparing open reduction and plate fixation with nonoperative treatment for displaced midshaft clavicle factures. Patients who were randomized to nonoperative treatment and who had healed by one year were included. Clavicle shortening relative to the uninjured contralateral clavicle was measured on 3DCT. Outcome analysis was conducted at six weeks, three months, six months and one year following injury and included the Disabilities of the Arm, Shoulder and Hand (DASH), Constant and Short Form-12 (SF-12) scores, and patient satisfaction. 48 patients were included. The mean shortening of injured clavicles, relative to the contralateral side, was 11mm (+/− 7.6mm) with a mean proportional shortening of 8percnt;. Proportional shortening did not significantly correlate with the DASH (p>0.42), Constant (p>0.32) or SF-12 (p>0.08) scores at any time point. There was no significant difference in the mean DASH or Constant scores at any followup time point both when the cut off for shortening was defined as one centimeter (p>0.11) or two centimeters (p>0.35). There was no significant difference in clavicle shortening between satisfied and unsatisfied patients (p>0.49). This study demonstrated no association between shortening and functional outcome or satisfaction in patients with healed, displaced, midshaft clavicle fractures up to one year following injury


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIII | Pages 16 - 16
1 Jul 2012
Murray I Foster C Robinson C
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Non-union has traditionally been considered a rare complication following the non-operative management of clavicle fractures. Recent studies demonstrate higher rates of non-union in adults with displaced fractures, yet the variables predicting non-union remain unclear. We evaluated the prevalence and risk factors for non-union following displaced midshaft clavicle fractures in a large consecutive series of patients managed non-operatively. 1097 consecutive adults (mean age 26.1yrs) with displaced midshaft clavicle fractures treated non-operatively in our Unit were included. All patients were interviewed, examined and underwent radiological assessment within a week of injury. All patients were managed in a sling for two weeks followed by early mobilization. All patients were followed-up until clinical and radiological confirmation of union. Non-union was defined clinically as pain or mobility of the fracture segments on stressing, and radiologically as failure of cortical bridging by 6 months. 198 (18%) of patients had evidence of non-union at 6 months. Patient factors associated with non-union included increasing age, smoking and the presence of medical comorbidities (p<0.05). Injury-related factors associated with non-union included increasing fragment translation and displacement, and injury pattern (Edinburgh 2B2: comminuted segmental fracture)(p<0.01). We present the largest series reporting prevalence and risk factors for non-union following conservatively treated, displaced midshaft clavicle fractures. These fractures can no longer be viewed as a single clinical entity, but as a spectrum of injuries each requiring individualized assessment and treatment. Increased understanding of the outcomes of these injuries will enable clinicians to better identify those patients that may be better served with primary operative reconstruction


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 119 - 119
1 Sep 2012
Murray I Foster C Robinson C
Full Access

Background. Non-union has traditionally been considered a rare complication following the non-operative management of clavicle fractures. A growing body of evidence has demonstrated higher rates of non-union in adults with displaced fractures. However, the variables that predict non-union in these patients remain unclear. We evaluated the prevalence and risk factors for non-union following displaced midshaft clavicle fractures in a large consecutive series of patients managed non-operatively in our Unit. Materials and Methods. 1097 consecutive adults (mean age 26.1yrs) with displaced midshaft clavicle fractures treated non-operatively in our Unit were included. All patients were interviewed and examined by an orthopaedic trauma surgeon and underwent radiological assessment within a week of injury. All patients were managed in a simple sling for two weeks followed by early mobilization. All patients were followed-up until clinical and radiological confirmation of union. Non-union was defined clinically as the presence of pain or mobility of the fracture segments on stressing, and radiologically as failure of cortical bridging by 6 months. Results. 198 (18%) of patients had evidence of non-union at 6 months. Patient factors significantly associated with non-union included increasing age, smoking and the presence of medical comorbidities (p<0.05). Injury-related factors associated with non-union included Increasing fragment translation and displacement, and a severe pattern of injury (Edinburgh 2B2: comminuted segmental fracture)(p<0.01). Conclusions. We present the largest series reporting the prevalence and risk factors for non-union following conservatively treated, displaced midshaft clavicle fractures. These fractures can no longer be viewed as a single clinical entity, but as a spectrum of injuries each requiring individualized assessment and treatment. Increased understanding of the outcomes of these injuries will enable clinicians to better identify those patients that may be better served with primary operative reconstruction


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_16 | Pages 55 - 55
1 Apr 2013
Kawakami Y Hiranaka T Niikura T Matsuzaki T Hida Y Uemoto H Doita M Tsuji M Kurosaka M
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Introduction. Plate fixations have been recommended for dislocated clavicle fractures. However, existing plates are inadequate for morphological compatibility with the clavicle. The aim of this study is to measure the anatomical shape of the clavicle and to compare the radiographical and clinical outcomes of our tree-dimensional (3D) reconstruction plate with conventional straight plate. Methods. Chest CT image of 15 patients with normal clavicle were analyzed. Their clavicles were reconstructed and measured their anatomical variables. A hospital-based case-control study was conducted, including a consecutive series of 52 patients with displaced midshaft clavicle fractures. 3D reconstruction plate was used for 26 patients and another 26 patients were treated with conventional straight plate. Outcome measures included the period of bone union, revision surgery, operating times and clinical symptoms using DASH score. Results. The result indicated that plates applying to any shape of the clavicle require a strong curve on the distal part and a twist on the proximal part. A case-control study demonstrated that the conventional straight plate group had higher rate of delayed union and had more symptomatic than the 3D group. Conclusion. The plates with a strong curve on the distal end and a twist on the proximal end exhibit better compatibility with the clavicle. Our 3D reconstruction plate showed superiority in both radiographical and clinical outcome than conventional straight ones


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1385 - 1391
1 Oct 2019
Nicholson JA Gribbin H Clement ND Robinson CM

Aims

The primary aim of this study was to determine if delayed clavicular fixation results in a greater risk of operative complications and revision surgery.

Patients and Methods

A retrospective case series was undertaken of all displaced clavicular fractures that underwent plate fixation over a ten-year period (2007 to 2017). Patient demographics, time to surgery, complications, and mode of failure were collected. Logistic regression was used to identify independent risk factors contributing towards operative complications. Receiver operating characteristic (ROC) curve analysis was used to determine if a potential ‘safe window’ exists from injury to delayed surgery. Propensity score matching was used to construct a case control study for comparison of risk.


The Bone & Joint Journal
Vol. 100-B, Issue 5 | Pages 624 - 633
1 May 2018
Maredza M Petrou S Dritsaki M Achten J Griffin J Lamb SE Parsons NR Costa ML

Aim

The aim of this study was to compare the cost-effectiveness of intramedullary nail fixation and ‘locking’ plate fixation in the treatment of extra-articular fractures of the distal tibia.

Patients and Methods

An economic evaluation was conducted from the perspective of the United Kingdom National Health Service (NHS) and personal social services (PSS), based on evidence from the Fixation of Distal Tibia Fractures (UK FixDT) multicentre parallel trial. Data from 321 patients were available for analysis. Costs were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality adjusted life year (QALY) gained, and net monetary benefit. Sensitivity analyses were conducted to test the robustness of cost-effectiveness estimates.